Frailty Clinical Trial
— STEP@HomeOfficial title:
Combating Hospital-related Function Decline Among Prefrail Older Adults: Pilot Testing of a Strength-based Tailored-Exercise Program at Home (STEP@Home)
This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | October 15, 2024 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - i) aged 60 or above, ii) prefrail as defined by a score of 1-2 on the Frail Scale (FS) which measures fatigue, resistance, ambulation, illness and weight loss over the last 4 weeks, iii) discharged home without any community care referral, iv) cognitively capable to receive exercise training as indicated by an Abbreviated Mental Test score of = 6, and v) consented to participate Exclusion Criteria: - (i) engaging in moderate or vigorous exercise (>60min/week) in the past 6 months, and (ii) with conditions contradictory to exercise training (e.g., acute muscular-skeletal problem, acute and unstable cardio-respiratory disease, etc). |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Alice Ho Miu Ling Nethersole Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The 5-item FRAIL Scale (FS) | measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity. | Baseline | |
Primary | The 5-item FRAIL Scale (FS) | measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity. | 10th week | |
Primary | The 5-item FRAIL Scale (FS) | measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity. | 20th week | |
Primary | The 5-item FRAIL Scale (FS) | measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity. | 28th week | |
Primary | The 11-item Edmonton Frail Scale | supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale. | Baseline | |
Primary | The 11-item Edmonton Frail Scale | supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale. | 10th week | |
Primary | The 11-item Edmonton Frail Scale | supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale. | 20th week | |
Primary | The 11-item Edmonton Frail Scale | supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale. | 28th week | |
Primary | The Short Physical Performance Battery (SPPB) | combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults. | Baseline | |
Primary | The Short Physical Performance Battery (SPPB) | combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults. | 10th week | |
Primary | The Short Physical Performance Battery (SPPB) | combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults. | 20th week | |
Primary | The Short Physical Performance Battery (SPPB) | combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults. | 28th week | |
Primary | The Life Space Assessment (LSA-C) | capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: living room other than the bedroom, ii) outside the house, iii) the neighborhood (within 800m of home), iv) outside the neighborhood (within 8km) and v) outside the town (beyond 16km). Example locations representing various distances from subjects' homes will be provided to facilitate the responses. The LSA-C has reliability of 0.88, with good criterion and construct validity. | Baseline | |
Primary | The Life Space Assessment (LSA-C) | capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: living room other than the bedroom, ii) outside the house, iii) the neighborhood (within 800m of home), iv) outside the neighborhood (within 8km) and v) outside the town (beyond 16km). Example locations representing various distances from subjects' homes will be provided to facilitate the responses. The LSA-C has reliability of 0.88, with good criterion and construct validity. | 10th week | |
Primary | The Life Space Assessment (LSA-C) | capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: living room other than the bedroom, ii) outside the house, iii) the neighborhood (within 800m of home), iv) outside the neighborhood (within 8km) and v) outside the town (beyond 16km). Example locations representing various distances from subjects' homes will be provided to facilitate the responses. The LSA-C has reliability of 0.88, with good criterion and construct validity. | 20th week | |
Primary | The Life Space Assessment (LSA-C) | capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: living room other than the bedroom, ii) outside the house, iii) the neighborhood (within 800m of home), iv) outside the neighborhood (within 8km) and v) outside the town (beyond 16km). Example locations representing various distances from subjects' homes will be provided to facilitate the responses. The LSA-C has reliability of 0.88, with good criterion and construct validity. | 28th week | |
Primary | European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L) | assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. It comprises a 5-level response set (5-L), including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a 0-100 visual analogue scale to measure perceived health. | Baseline | |
Primary | European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L) | assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. It comprises a 5-level response set (5-L), including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a 0-100 visual analogue scale to measure perceived health. | 10th week | |
Primary | European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L) | assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. It comprises a 5-level response set (5-L), including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a 0-100 visual analogue scale to measure perceived health. | 20th week | |
Primary | European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L) | assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. It comprises a 5-level response set (5-L), including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a 0-100 visual analogue scale to measure perceived health. | 28th week | |
Primary | Unplanned hospital readmissions | will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals. | Baseline | |
Primary | Unplanned hospital readmissions | will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals. | 10th week | |
Primary | Unplanned hospital readmissions | will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals. | 20th week | |
Primary | Unplanned hospital readmissions | will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals. | 28th week |
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